The following data is part of a premarket notification filed by Somnus Medical Technologies, Inc. with the FDA for Somnus Medical Tech Soft Tissue Coagulating Electrode.
| Device ID | K961132 |
| 510k Number | K961132 |
| Device Name: | SOMNUS MEDICAL TECH SOFT TISSUE COAGULATING ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SOMNUS MEDICAL TECHNOLOGIES, INC. 21070 HOMESTEAD RD. Cupertino, CA 94043 |
| Contact | Thomas C Wehman |
| Correspondent | Thomas C Wehman SOMNUS MEDICAL TECHNOLOGIES, INC. 21070 HOMESTEAD RD. Cupertino, CA 94043 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-21 |
| Decision Date | 1996-05-22 |